Exciting Phase 2 Trial Results for Spevatamig Show Promise in Treating Metastatic PDAC

Phase 2 Trial Results of Spevatamig in Metastatic PDAC

Phanes Therapeutics, a biotech company focused on oncology, made headlines during the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) 2026 by releasing positive results from the ongoing TWINPEAK study. This study involves the innovative bispecific antibody, spevatamig (PT886), which targets claudin 18.2 and CD47, showcasing its potential as a first-line treatment combined with chemotherapy for patients suffering from metastatic pancreatic ductal adenocarcinoma (mPDAC).

Promising Efficacy in Metastatic PDAC Patients

The latest data presented at ASCO GI 2026 reveal that spevatamig, when given alongside GnP (gemcitabine and nab-paclitaxel), displayed significant efficacy. Among patients receiving a weekly dose of 2 mg/kg spevatamig, the study recorded a disease control rate (DCR) of 93% and an overall response rate (ORR) of 40%, with six patients achieving a partial response. The findings suggest that spevatamig could potentially enhance treatment outcomes for mPDAC patients, who notoriously face limited therapeutic options.

Additionally, the study provided insight into patient survival. The median progression-free survival (mPFS) was documented at 7.3 months, with a six-month PFS rate of 59%. On overall survival, the median OS reached 13.2 months, with a remarkable six-month OS rate of 93%. Notably, responses were consistent across patients with CLDN18.2 expression scores of 10% or higher, with 85% of screened patients meeting this requirement.

Safety and Tolerability Strengths

One of the standout features of spevatamig is its favorable safety profile. In the study, no cases of cytokine release syndrome (CRS) or dose-limiting toxicities (DLTs) were reported. Furthermore, no instances of grade 3 or greater treatment-emergent anemia, neutropenia, or thrombocytopenia occurred during the trial. Dosing reductions or treatment discontinuations due to gastrointestinal side effects were also absent, highlighting spevatamig's potential for improved tolerability compared to existing therapies.

The combination regimen of spevatamig with GnP has shown to reduce the common adverse effects associated with chemotherapy, such as nausea and vomiting. In fact, the rates of anemia and other blood-related side effects were found to be comparable to historical data from GnP trials, reinforcing spevatamig's promise in enhancing patients’ quality of life during treatment.

Future Directions and Implications

The TWINPEAK study is significant not only for mPDAC but also for broader cancer research, as spevatamig represents a novel category of immunotherapy known as an innate immunity enhancer (I2E). In 2024, the FDA has already granted it Fast Track designation for treating claudin 18.2-positive mPDAC, indicating the agency acknowledges the urgent need for effective treatments in this area.

Moreover, Phanes Therapeutics is expanding its commitment to this therapeutic route by entering collaborations with other major pharmaceutical players to evaluate spevatamig in combination with different cancer therapies, including potential synergy with immune checkpoint inhibitors.

Overall, Phanes Therapeutics has positioned spevatamig as a beacon of hope for mPDAC patients, not just with its committed research and development approach, but also through the robust early trial outcomes that indicate a significant advancement in the fight against this aggressive cancer. As the clinical trial progresses, the oncology community will be keenly interested in continued updates that could shape future treatment landscapes for patients worldwide.

For additional information regarding their research findings, you can visit Phanes Therapeutics’ official science page here.